Trial Outcomes & Findings for The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy (NCT NCT02673515)

NCT ID: NCT02673515

Last Updated: 2020-05-28

Results Overview

HOMA-Index was calculated by using the following formula: HOMA-IR= FPG(mmol/l)\*FSI (U/l)/22.5 FSI=fasting serum insulin FPG=fasting plasma glucose

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

4 weeks (from Baseline to 4 weeks)

Results posted on

2020-05-28

Participant Flow

After interviewing 462 adults for study eligibility based on previously set inclusion and exclusion criteria we have selected 60 representative study participants for the randomized controlled trial.

Participant milestones

Participant milestones
Measure	Alternate Day Fasting Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group participants in the control group should be remaining on their usual diet
Overall Study STARTED	30	30
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Alternate Day Fasting Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group participants in the control group should be remaining on their usual diet
Overall Study Lack of motivation	2	1

Baseline Characteristics

per protocol analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alternate Day Fasting n=30 Participants Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group n=30 Participants participants in the control group should be remaining on their usual diet	Total n=60 Participants Total of all reporting groups
Age, Continuous	48 years n=30 Participants	50.5 years n=30 Participants	49 years n=60 Participants
Sex: Female, Male Female	17 Participants n=28 Participants • per protocol analysis	17 Participants n=29 Participants • per protocol analysis	34 Participants n=57 Participants • per protocol analysis
Sex: Female, Male Male	11 Participants n=28 Participants • per protocol analysis	12 Participants n=29 Participants • per protocol analysis	23 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants • per protocol analysis	0 Participants n=29 Participants • per protocol analysis	0 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) Asian	0 Participants n=28 Participants • per protocol analysis	0 Participants n=29 Participants • per protocol analysis	0 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants • per protocol analysis	0 Participants n=29 Participants • per protocol analysis	0 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) Black or African American	0 Participants n=28 Participants • per protocol analysis	0 Participants n=29 Participants • per protocol analysis	0 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) White	28 Participants n=28 Participants • per protocol analysis	29 Participants n=29 Participants • per protocol analysis	57 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) More than one race	0 Participants n=28 Participants • per protocol analysis	0 Participants n=29 Participants • per protocol analysis	0 Participants n=57 Participants • per protocol analysis
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants • per protocol analysis	0 Participants n=29 Participants • per protocol analysis	0 Participants n=57 Participants • per protocol analysis
Body weight	77.21 kg STANDARD_DEVIATION 10.25 • n=28 Participants • per protocol analysis	75.93 kg STANDARD_DEVIATION 12.50 • n=29 Participants • per protocol analysis	77.03 kg STANDARD_DEVIATION 11.90 • n=57 Participants • per protocol analysis

PRIMARY outcome

Timeframe: 4 weeks (from Baseline to 4 weeks)

Population: per protocol analysis

HOMA-Index was calculated by using the following formula: HOMA-IR= FPG(mmol/l)\*FSI (U/l)/22.5 FSI=fasting serum insulin FPG=fasting plasma glucose

Outcome measures

Outcome measures
Measure	Alternate Day Fasting n=28 Participants Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group n=29 Participants participants of the control group should be remaining on their usual diet
Insulin Sensitivity (HOMA-IR)	0.05 no unit Standard Deviation 0.95	0.06 no unit Standard Deviation 0.80

PRIMARY outcome

Timeframe: 4 weeks (from Baseline to 4 weeks)

Population: per protocol analysis

QUICKI was calculated by using the following formula: QUICKI= log(FSI)+log (FPG) FSI=fasting serum insulin FPG=fasting plasma glucose

Outcome measures

Outcome measures
Measure	Alternate Day Fasting n=28 Participants Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group n=29 Participants participants of the control group should be remaining on their usual diet
Insulin Sensitivity (QUICKI)	0 no unit Interval -0.02 to 0.02	0 no unit Interval -0.03 to 0.01

PRIMARY outcome

Timeframe: 4 weeks (from Baseline to 4 weeks)

Population: per protocol analysis

ISI was calculated by using the following formula: ISI=0,222-0,00333 x BMI-0,0000779 x Ins120-0,000422 x age FSI=fasting serum insulin FPG=fasting plasma glucose

Outcome measures

Outcome measures
Measure	Alternate Day Fasting n=28 Participants Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group n=29 Participants participants of the control group should be remaining on their usual diet
Insulin Sensitivity (ISI-Index)	0 no unit Interval 0.0 to 0.01	0 no unit Interval 0.0 to 0.01

PRIMARY outcome

Timeframe: 4 weeks (from Baseline to 4 weeks)

Population: per protocol analysis

Matsuda index was calculated by using the following formula: Matsuda-Index = 10000√(FPG∗FSI)∗(mean glucose\*mean insulin) FSI=fasting serum insulin FPG=fasting plasma glucose

Outcome measures

Outcome measures
Measure	Alternate Day Fasting n=28 Participants Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group n=29 Participants participants of the control group should be remaining on their usual diet
Insulin Sensitivity (Matsuda-Index)	-0.4 no unit Interval -4.6 to 3.3	-0.7 no unit Interval -5.4 to 1.8

SECONDARY outcome

Timeframe: 4 weeks

Population: per protocol analysis

Change of blood pressure from Baseline to 4 weeks

Outcome measures

Outcome measures
Measure	Alternate Day Fasting n=28 Participants Subjects are requested to alternate fast for 4 weeks (alternate an ad libitum "feed day" with a 100% restriction "fast day"). Alternate day fasting: Subjects are requested to fast every other day. Calorie free fluids are allowed.	Control Group n=29 Participants participants of the control group should be remaining on their usual diet
Blood Pressure (Systolic and Diastolic) Systolic blood pressure	-4.5 mmHg Interval -7.75 to -0.5	-1 mmHg Interval -6.0 to 7.0
Blood Pressure (Systolic and Diastolic) Diastolic blood pressure	-2.5 mmHg Interval -4.0 to 1.0	0 mmHg Interval -3.5 to 2.5

Adverse Events

Alternate Day Fasting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assoc.-Prof.Dr. Harald Sourij

Medical University of Graz

Phone: +43 316 385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place